• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP CONSOLE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP CONSOLE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE Back to Search Results
Model Number 60-03-75
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/11/2019
Event Type  malfunction  
Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump console.The incident occurred in (b)(6).Livanova (b)(4) initiated an investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
 
Event Description
Livanova (b)(4) received a report of a broken speed control knob on a centrifugal pump console during procedure.There was no report of patient injury.
 
Event Description
See initial report.
 
Manufacturer Narrative
Replaced the shaft encoder.Livanova technician performed final verification testing and device return to customer.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CENTRIFUGAL PUMP CONSOLE
Type of Device
PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key9166256
MDR Text Key194967476
Report Number9611109-2019-00787
Device Sequence Number1
Product Code KFM
Combination Product (y/n)N
PMA/PMN Number
K020571
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number60-03-75
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/11/2019
Initial Date FDA Received10/08/2019
Supplement Dates Manufacturer Received11/28/2019
Supplement Dates FDA Received12/27/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-